Manager, Regulatory Compliance

Manager, Regulatory Compliance

Location US-WA-Bothell Position Type Full Time Work Model Hybrid

Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific.

Overview The Manager, Regulatory Compliance will lead Verathon's compliance team with focus on internal / external audits, European compliance, distributor and service partner compliance, sterilization oversight, management reviews, and QMS updates. This manager will report to the VP Quality & Regulatory and will lead a small team as well as complete individual contributor tasks. This manager will coordinate cross-functionally and sustain year-round inspection readiness.

Responsibilities Plan, lead, and continually improve the internal audit program; ensure effective risk-based coverage and timely closure of findings. Lead and coordinate external inspections and audits by regulators, Notified Bodies, and MDSAP Auditing Organizations, including front-room / back-room operations and rapid response management. Lead audit finding response management (containment, root cause, corrective action, effectiveness verification) and track commitments to on-time closure. Maintain EU audit / inspection readiness and post-audit follow-through in collaboration with relevant EU stakeholders and company leadership. Establish and maintain compliance qualification, due diligence, and ongoing monitoring programs for distributors and service partners. Implement agreements, training, and periodic assessments; ensure complaint handling, traceability, field action support, and recordkeeping meet company requirements. Own the sterilization validation process, routine control evidence, and change impact assessments with manufacturing and suppliers. Audit and manage performance of sterilization service providers in collaboration with Supply Chain / Operations. Lead management reviews including gathering inputs, metrics / KPIs, minutes, and action tracking to effectiveness. Manage Regulatory Compliance Specialists and support staff; set objectives, coach performance, and build audit / inspection skills across the team. Provide clear guidance to functional partners on readiness, roles, and communication during audits and inspections.

Qualifications Bachelor's degree in a scientific or engineering discipline (or equivalent experience). A minimum of 3 years' experience working in a regulated environment. A minimum of 2 years' people leadership. Lead Auditor or ASQ Certification is preferred. Proven experience leading confidently under pressure during external audits. Must be a critical thinker, detailed oriented with strong, structured, critical thinking skills, able to lead multiple team members and effectively balance priorities. Must have proven experience working collaboratively in cross functional teams to continually improve a quality system. Direct experience maintaining distributor and service partner compliance programs. Practical knowledge of sterilization oversight (validation status, routine control)